Physicians Committee for Responsible Medicine
Washington D.C., District of Columbia, 20016, United States
NCT Number: NCT04587154
This study tests the hypothesis that a low-fat, vegan diet including soybeans reduces the frequency and severity of menopausal hot flashes, and tests the hypothesis that total isoflavone intake is associated with the reduction in the frequency and severity of hot flashes.
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Notify Me40 year–60 year
Female
Interventional
Not applicable
Washington D.C., District of Columbia, 20016, United States
Women with postmenopausal hot flashes will be recruited via social media and randomly assigned to an intervention or control group. The intervention group will be asked to consume a low-fat, vegan diet including ½ cup (86g) cooked soybeans (30 g uncooked) for 12 weeks. Support will be provided by weekly meetings conducted via an Internet video conferencing platform (e.g., Zoom), along with individual counseling as needed. The control group will be asked to make no diet changes for 12 weeks but will be offered instruction in how to follow a vegan diet and about the potential role of soybeans after the 12-week point. The frequency and severity of hot flashes will be assessed before, during, and after the 12-week intervention.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.
Other names: Vegan diet
Time frame: 12 weeks
Incidents Induced by Menopause. Hot flashes will be recorded using the MyLuna application, available in the App Store for iPhone or Android.
Time frame: 12 weeks
Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)
Time frame: 12 weeks
Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.
Time frame: 16 weeks
Explore the effectiveness of a vegan diet in reducing dietary AGEs.
Time frame: 16 weeks
Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.
Time frame: 16 weeks
The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.
Time frame: 16 weeks
The greenhouse gas emissions (GHGE) and cumulative energy demand (CED) will be assessed, using the database of Food Impacts on the Environment for Linking to Diets (dataFIELD) and What We Eat In America (WWEIA) database, at baseline and 16 weeks.
Physicians Committee for Responsible Medicine
Other
Acronym: WAVS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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